Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

NCT ID: NCT01346436

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2020-05-31

Brief Summary

The purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.

Detailed Description

Pelvic floor dysfunction is a common pathology. The management can be medical or surgical, depending on the location or the severity of the disease.

Since the large use of laparoscopy for the treatment of pelvic floor dysfunction, interesting and encouraging results have been published.

However, so far, a laparoscopic approach has some technical disadvantages like a poor ergonomy, a 2 dimensional vision, an unstable camera and the use of straight instruments. To overcome these natural limitations, robotics has been gaining increasing acceptance in general surgery.

Several groups have reported their encouraging experience with robotic rectopexy. Yet, these studies were not randomized or double blinded.

The aim of this study is to evaluate the role of robotics for complex pelvic floor dysfunction and to compare the outcomes to the laparoscopic approach.

Conditions

Rectal Prolapse; Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robotic

Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction

Group Type: ACTIVE_COMPARATOR

Minimally invasive rectopexy

Intervention Type: PROCEDURE

Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy

Laparoscopy

Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction

Group Type: ACTIVE_COMPARATOR

Minimally invasive rectopexy

Intervention Type: PROCEDURE

Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy

Interventions

Minimally invasive rectopexy

Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy

Intervention Type: PROCEDURE

Other Intervention Names

Surgery for rectal prolapse

Eligibility Criteria

Inclusion Criteria

• women
• proven pelvic floor dysfunction
• informed consent

Exclusion Criteria

• Age <18 years old
• Patient unable to communicate or to understand the study
• Patient refusing to participate to the study
• contraindication to laparoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nicolas C. Buchs

OTHER

Sponsor Role: lead

Responsible Party

Nicolas C. Buchs

Faculty surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicolas C Buchs, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital of Geneva, Department of Surgery

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Nicolas C Buchs, MD

Role: CONTACT

nicolas.c.buchs@hcuge.ch

+41 79 553 2683

Facility Contacts

Nicolas C Buchs, MD

Role: primary

nicolas.c.buchs@hcuge.ch

+41 553 2683

Other Identifiers

CER-11-047

Identifier Type: -

Identifier Source: org_study_id